Fast 96-Well Background Calibration Plate

GUDID 10190302000765

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Nucleic acid hybridization detection IVD, reagent
Primary Device ID10190302000765
NIH Device Record Key7e24dde2-54a7-4801-9f97-3b75c6f731fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameFast 96-Well Background Calibration Plate
Version Model Number4481308
Company DUNS628548377
Company NameLIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110190302000765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2020-01-22
Device Publish Date2016-08-01

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